NCT06959563

Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV

Conducting an Early Phase Clinical Trial to Assess for HPV Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of HPV Patients

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Industry
• Sex: Female
• Age: 24 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients. 1. Treat Infection of Multiple HPV Virus Strains via Trained Immunity. 2. Activate human HPV Antigen Presentation Reaction. 3. The human antigen presenting cells (APCs) can treat the HPV virus protein antigens into small peptide fragments, and then clear HPV virus in vivo.

Detailed description

* Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients * 20 Cervical HPV Infection Patients * Positive testing HPV by standard PCR assay * HPV infection without symptoms * No clinical signs indicative of oncology * TB negative participant is negative IGRA blood test with TB antigens * 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative testing HPV by standard PCR assay after percutaneous 21 days * Positive IGRA blood test with HPV protein antigen after percutaneous use 21 days * Our trial duration will be 12-week duration.

Conditions

• HPV Infection

Interventions

Type	Name	Description
BIOLOGICAL	9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use	By the percutaneous route with the multiple puncture device - 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix

Timeline

• Start date: 2025-04-28
• Primary completion: 2026-09-18
• Completion: 2026-09-28
• First posted: 2025-05-06
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study